Due
to the popularity of the Internet, access to the delivery of health care is
rapidly changing. The Internet is described as the world's largest computer
network. In January 1995, there were approximately 4,852,000 people connected to
the Internet (Pallen, 1995). There are thousands of health related topics
available on the Internet. The American Association of Family Physicians stated
that Email use alone has grown from as estimated 100,000 addresses in 1970 to
over 100 million in 2000 (Kane & Sands, 1998). The Internet allows both
communication and provision of services between patients and providers
(Ferguson, 1998). The Internet has created countless opportunities for patients
to access not only health-related information, but also products and services
like online pharmacies. The Internet offers convenience and privacy for persons
buying online products such as medications (Ferguson, 1998). It is the disabled,
the elderly, and patients living in remote areas that via the Internet can more
easily obtain information, products, and services that were previously acquired
only with great difficulty (FDA, 2001). These Internet customers become easy
targets for unethical and illegal online pharmacies (FDA, 2001). This paper
addresses how some online pharmacies breach the ethical principles as well as
laws that govern Internet services. The principles of nonmaleficence (or doing
no harm) and beneficence (or doing good) will be examined in reference to the
questionable practices of various online pharmacies. This paper also discusses
the federal and state measures that are being established to help prevent the
breaking of laws and the breach of such ethical principles as nonmaleficence.

A
Breach in Ethical Princip1es

The
definition of online pharmacy is a legitimate pharmacy site on the Internet that
provides consumers with a convenient and private way to obtain prescribed
medications, sometimes at a more affordable price than regular pharmacies.
Online pharmacies provide the elderly and persons in remote areas quick access
and an easy and convenient way to purchase medications (FDA, 2001). Reputable
Internet pharmacies allow patients to consult with a licensed pharmacist from
the privacy of their homes. Legitimate online pharmacies only fill prescriptions
prescribed by physicians and they use safe and legal medications (Henney &
Shurren, 1999).

The
increase in access to health care services by individuals with home computers
and access to the Internet has created an avenue for unscrupulous online
pharmacy sites to easily breach both the legal and the ethical principles (FDA,
2001 ). Nonmaleficence (doing no harm) and beneficence (doing good) are ethical
principles that some of these online pharmacies seem to ignore (Bradley-Popovich,
2000). For example, nonmaleficence is an ethical principle that is breached when
an illegal pharmacy puts a patient at risk by sending out contaminated or
counterfeit products. Nonmaleficence is also breached when the patient is sent
the wrong product, an incorrect dosage, or possibly no product at all (FDA,
2001).

Online
pharmacies not only breach ethical principles that are considered essential in
standard health care practice, they also break federal laws (FDA, 2001). The
pharmacies that break laws and breach the ethical principle of nonmaleficence,
are putting patients at risk for dangerous drug interactions and other serious
health consequences, because many of them do not require the patient to have a
prescription written by a physician (FDA, 2001). One other problem with illegal
online pharmacies is that their products are not FDA approved (www.fda.gov/oc/buyonline/faqs.html).
They sell products that are similar but not identical formulations of FDA
approved products (FDA, 2001). The products are often not stored or distributed
under the quality conditions required by the United States and therefore cannot
be legally sold in the US (FDA, 2001). These drugs may be legal to sell in a
foreign country, such as Mexico, but this does not make it legal to sell them in
the US, even by the Internet (FDA, 2001). All of these factors add to a breach
of the ethical principles of nonmaleficence (Bradley-Popovich, 2000). The
principles of doing no harm is breached because patients lives are put in harms
way by breaking the FDA rules and laws (FDA, 2001) to the benefit of illegal
health service providers.

The
online pharmacies where the problems usually originate are the pharmacies that
are not licensed by the National Association of Boards of Pharmacy (FDA, 2001).
These online pharmacies usually offer to prescribe a drug for the first time
without a physical exam, physician, or registered pharmacist involved in the
process (www.fda.gov/co/buyonline.faqs.html). This is a direct ethical breach of
nonmaleficence. Without a licensed provider prescribing the drug potential harm
becomes an issue. Adding to this breach in ethics is the fact that many online
pharmacies do not have access to a registered pharmacist to check medications
and to answer patients' questions (FDA, 2001).

The
people affected for the most part by the use of technology for illegal and
unethical practice include the disabled, the elderly, and patients living in
remote areas of the country. However, everyone using the Internet could be
adversely affected. The major players who run these illegitimate online
pharmacies, often from Web sites originating in foreign countries such as
Mexico, are talented enough to make the site appear to be associated with a
legitimate pharmacy when in fact they are not legal in the US in accordance with
FDA laws (FDA, 2001). Web sites that sell prescription drugs without a valid
written prescription deny consumers the protection provided by an examination
conducted by a licensed practitioner, again, breaches of nonmaleficence and
beneficence (FDA, 2001).

Reporting
the Ethical Offenders

These
types of unethical practices often go underreported and the FDA believes the
occurrence of these problems will only increase (FDA, 2001). It is estimated
that some 41 million Americans will use online pharmacies over the next 4 years
(FDA, 2001). The 2001 congressional budget is expected to include new federal
requirements for all Internet pharmacies (Fleming, 2000). New civil penalties
for the illegal sale of pharmaceuticals will be put in place and more authority
will be given to federal agencies to prosecute offenders (Fleming, 2000). There
is also a new federal public educational campaign that is being organizedthrough
the World Health Organization (WHO) and the FDA to educate citizens about the
potential dangers of buying prescription drugs online (WHO, 2001).

In
2000, the Clinton Administration established a new federal requirement to enable
consumers to identify legitimate Internet pharmacy sites (Fleming, 2000).
According to this new requirement, providers have to demonstrate to the FDA that
they comply with federal and state laws before receiving approval to operate and
this designation will be documented at the Web site. Sites operating without
doing so will face government sanctions (Fleming, 2000). Other Congressional
safeguards to protect patients from injuries resulting from unsafe and
counterfeit drugs were enacted long before the development of the Internet (Henney
& Shurren, 1999). However, the sale of drugs on the Internet makes it easy
to bypass this Congressional risk-management system (Henney & Shurren,
1999). Several federal agencies including the FDA and the US Customs
Service" detain illegal products when they enter the country (Henney &
Shurren, 1999).

The
FDA posts at its Web site the names of several illegal drugs it has detained.
However, the absence of a particular product or business from the detention list
does not indicate that importation of their product is legal or that the FDA has
not detained their products (Henney & Shurren, 1999). The FDA always tries
to work with foreign governments to prosecute the seller in these cases, this
includes online pharmacies (Henney & Shurren, 1999).

The
World Health Organization and the FDA are collaborating on developing a guide
entitled Medical Products and the Internet (WHO, 2001). In addition to providing
tips on finding reliable health and medical information on the Internet, the
guide will provide advice to consumers about buying medical products online. In
May 1998, the 51st World Health Assembly requested that the Director-General of
the World Health Organization develop a guide on medical products and the
Internet (WHO, 2001). The guide is intended to serve as a model for member
states who can adapt it into locally meaningful advice for Internet users, to
help them obtain reliable, independent, and comparable information on medicinal
products while ethical principles are practiced appropriately. This guide was
developed in consultation with drug regulatory authorities, drug information
experts, consumer organizations, and the pharmaceutical industry .It is a model
guide, designed to be translated into national languages and modified as the
local situation may require (WHO, 2001). It is the hope of the FDA that
educating Internet users by adding information guides to their site concerning
online pharmacies, will make the reporting of illegitimate online pharmacies
easier and help to alleviate unethical practices of breaching the principles of
nonmaleficence and beneficence. Educating the consumer to properly report
offenders will make it easier to locate online pharmacies in violation of the
Federal Food, Drug and Cosmetic Act (FDA, 2001).

The
proper education of Internet users, about laws governing online pharmacies, is
paramount in this process. The FDA wants all Internet online pharmacy users to
understand the laws that are already in place. F or example, as a general matter
it is illegal to import an unapproved drug into the US (FDA, 2001). There are
exceptions to this rule in cases of serious conditions but patients must be
granted special privileges (FDA, 2001). It is also important to know that it is
illegal for anyone, including a foreign pharmacy, to ship prescription drugs,
not approved by the FDA, into the US even though the drug may be legal to sell
in the originating country (FDA, 2001). The FDA also wants consumers to know
that Congress: a) requires that drugs be tested, b) test results must be
reviewed by the FDA, and c) the formulation must be approved by the FDA (FDA,
2001). Understanding and observing these rules will also increase the likelihood
of discovering breaches of ethics such as nonmaleficence and beneficence. An
extremely important point for Internet users to remember is that products with
similar but not identical formulations passed as FDA approved products, and
products not made under the quality standards required by US law or labeled
according to US requirements cannot be legally sold in the US (FDA, 2001). Also,
prescription drugs, available from a foreign pharmacy, that are products that
the FDA has not approved, and products not stored or distributed under the
quality conditions required in the US cannot be legally sold in and/or online in
the US (FDA, 2001).

Conclusion

In
conclusion, on-line drug sales that bypass the traditional safeguards imposed by
the US Congress and state legislatures, have physicians and pharmacies not only
breaking the law but also breaching the ethical principles of nonmaleficence and
beneficence. This in turn puts Internet users of online pharmacies in the United
States at risk. The education of the general public concerning the laws and the
ethical principles, could help to control this problem. Internet users of online
pharmacy web sites must learn to check with the National Association of Boards
of Pharmacy (FDA, 2001) to validate each online pharmacy before using its Web
site. Until appropriate safeguards have been fully implemented, patients and
practitioners must be cautious and observe to see if any of the ethical
principles have been breached or laws have been broken when visiting any on-line
pharmaceutical site.